Cleared Traditional

ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS

K102699 · Abbott Laboratories · Toxicology
Apr 2011
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K102699 is an FDA 510(k) clearance for the ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS, a Enzyme Immunoassay, Gentamicin (Class II — Special Controls, product code LCD), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 1, 2011, 193 days after receiving the submission on September 20, 2010. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K102699 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2010
Decision Date April 01, 2011
Days to Decision 193 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCD — Enzyme Immunoassay, Gentamicin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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